Pfizer Inc. and Valneva SE announce that Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the US who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.
GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. These standards are designed to put participants
